The following data is part of a premarket notification filed by Genetic Laboratories, Inc. with the FDA for Suture Strip.
| Device ID | K842621 |
| 510k Number | K842621 |
| Device Name: | SUTURE STRIP |
| Classification | Strip, Adhesive, Closure, Skin |
| Applicant | GENETIC LABORATORIES, INC. 1385 DENTENNIAL DRIVE St. Paul , MN 55113 - |
| Contact | Daniel G Holman |
| Correspondent | Daniel G Holman GENETIC LABORATORIES, INC. 1385 DENTENNIAL DRIVE St. Paul , MN 55113 - |
| Product Code | FPX |
| CFR Regulation Number | 880.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-05 |
| Decision Date | 1984-10-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUTURE STRIP 74021832 1697316 Live/Registered |
Genetic Laboratories Wound Care, Inc. 1990-01-23 |
![]() SUTURE STRIP 73481080 1370707 Dead/Cancelled |
GENETIC LABORATORIES, INC. 1984-05-21 |